Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025

Core Insights - Tonmya has been approved by the FDA for the treatment of fibromyalgia, marking the first new FDA-approved treatment for this condition in over 15 years [1][9] - The approval is supported by two pivotal Phase 3 studies demonstrating significant pain reduction compared to placebo and consistent improvements in core fibromyalgia symptoms [1][2] - Tonmya is expected to be commercially available in the fourth quarter of 2025 [1] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [9] - The company focuses on central nervous system disorders, immunology, immuno-oncology, and infectious diseases [9] - Tonix also markets treatments for acute migraine and is developing TNX-102 SL for acute stress reaction and acute stress disorder [9] Product Details - Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, designed for rapid absorption and reduced production of a long half-life active metabolite [5][6] - The drug targets nonrestorative sleep through receptor antagonism, addressing a central mechanism believed to drive fibromyalgia symptoms [2][5] - Tonmya is indicated for once-daily bedtime use in adults with fibromyalgia [6][13] Clinical Trials - The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials that enrolled 503 and 457 adults, respectively [7][8] - Both trials demonstrated significant pain reduction and a favorable tolerability profile for Tonmya [2][7] - The primary endpoint was the change in daily diary pain intensity score from baseline to Week 14 [7] Market Context - Fibromyalgia affects an estimated 10 million adults in the U.S., with approximately 80% being women [4] - Patients with fibromyalgia incur double the medical costs compared to the general population [4] - The availability of a new, non-opioid treatment option like Tonmya may improve patient outcomes and support earlier diagnosis and intervention [2][4]